Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00835198
• Collaborator: (none)
• Enrollment: 163
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 20.4

Study Details

Study Description

Brief Summary

A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Dapsone; Tretinoin; Drug: Tretinoin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 163 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Dapsone gel 5% and Tretinoin gel 0.025%	Drug: Dapsone; Tretinoin; Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks; Other Names: Aczone Gel 5%; Tretin-X Gel 0.025%
Active Comparator: 2 Tretinoin gel 0.025%	Drug: Tretinoin; Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks; Other Names: Tretin-X Gel 0.025%

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 [Baseline, Week 12]

   Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).

Secondary Outcome Measures

1. Change From Baseline in Investigator Global Assessment at Week 12 [Baseline, Week 12]

   Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).

2. Change From Baseline in Overall Disease Severity at Week 12 [Baseline, Week 12]

   Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).

3. Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 [Baseline, Week 12]

   Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or "pimples") lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Facial acne vulgaris characterized by the following:

• 30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions;

• Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm)

• Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study

Exclusion Criteria:

• Non-compliance with washout period;

• History of clinically significant anemia or hemolysis;

• Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris;

• Allergy or sensitivity to any component of the test medications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Strongsville	Ohio	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00835198
• Other Study ID Numbers: MA-ACZ0801
• First Posted: Feb 3, 2009
• Last Update Posted: Oct 31, 2011
• Last Verified: Sep 1, 2011

• Additional relevant MeSH terms: Acne Vulgaris; Dapsone; Tretinoin

Study Results

Participant Flow

Arm/Group Title	Tretinoin Gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025%
Arm/Group Description	Tretinoin gel 0.025%	Dapsone gel 5% and Tretinoin gel 0.025%
Period Title: Overall Study
STARTED	82	81
COMPLETED	74	74
NOT COMPLETED	8	7

Baseline Characteristics

Arm/Group Title	Tretinoin Gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025%	Total
Arm/Group Description	Tretinoin gel 0.025%	Dapsone gel 5% and Tretinoin gel 0.025%	Total of all reporting groups
Overall Participants	82	81	163
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	20.2	19.7	20.0
Sex: Female, Male (Count of Participants)
Female	44 53.7%	38 46.9%	82 50.3%
Male	38 46.3%	43 53.1%	81 49.7%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12
Description	Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT), which included all patients who started the study (randomized).

Arm/Group Title	Tretinoin Gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025%
Arm/Group Description	Tretinoin gel 0.025%	Dapsone gel 5% and Tretinoin gel 0.025%
Measure Participants	82	81
Baseline	38.96 (6.3)	40.06 (9.4)
Week 12	-24.05 (13.02)	-25.82 (12.36)

2. Secondary Outcome

Title	Change From Baseline in Investigator Global Assessment at Week 12
Description	Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT), which included all patients who started the study (randomized).

Arm/Group Title	Tretinoin Gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025%
Arm/Group Description	Tretinoin gel 0.025%	Dapsone gel 5% and Tretinoin gel 0.025%
Measure Participants	82	81
Baseline	3.02 (0.47)	2.99 (0.43)
Week 12	-1.07 (0.85)	-1.08 (0.89)

3. Secondary Outcome

Title	Change From Baseline in Overall Disease Severity at Week 12
Description	Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT), which included all patients who started the study (randomized).

Arm/Group Title	Tretinoin Gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025%
Arm/Group Description	Tretinoin gel 0.025%	Dapsone gel 5% and Tretinoin gel 0.025%
Measure Participants	82	81
Baseline	4.14 (0.72)	4.05 (0.77)
Week 12	-1.79 (1.21)	-1.76 (1.29)

4. Secondary Outcome

Title	Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
Description	Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or "pimples") lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT), which included all patients who started the study (randomized).

Arm/Group Title	Tretinoin Gel 0.025%	Dapsone Gel 5% and Tretinoin Gel 0.025%
Arm/Group Description	Tretinoin gel 0.025%	Dapsone gel 5% and Tretinoin gel 0.025%
Measure Participants	82	81
Baseline	40.94 (11.13)	40.69 (10.17)
Week 12	-19.91 (13.2)	-15.81 (21.3)

Adverse Events

Arm/Group Title	Tretinoin Gel 0.025%		Dapsone Gel 5% and Tretinoin Gel 0.025%
Arm/Group Description	Tretinoin gel 0.025%		Dapsone gel 5% and Tretinoin gel 0.025%
All Cause Mortality
	Tretinoin Gel 0.025%		Dapsone Gel 5% and Tretinoin Gel 0.025%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Tretinoin Gel 0.025%		Dapsone Gel 5% and Tretinoin Gel 0.025%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0%)		0/81 (0%)
Other (Not Including Serious) Adverse Events
	Tretinoin Gel 0.025%		Dapsone Gel 5% and Tretinoin Gel 0.025%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/82 (14.6%)		10/81 (12.3%)
Infections and infestations
Cold	8/82 (9.8%)		7/81 (8.6%)
Nervous system disorders
Headache	4/82 (4.9%)		3/81 (3.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo